Analyst I, Postmarket Surveillance

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Title

Analyst I Postmarket Surveillance

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plano, Texas location in the Heart Failure Division of Abbott. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Under the direction of the department manager, the Product Surveillance Analyst may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for SJM. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering).

Another role of the Product Surveillance Analyst is that of performing evaluations of returned complaint products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings and customer letters, operating and maintaining the Product Surveillance Laboratory and equipment, and collecting and evaluating analysis data. The Product Surveillance Analyst will also be able to perform trending of complaint data in either role as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department Data Analyst. Depending on the site location of the PS Analyst, they may perform both complaint investigations and product analysis.

What You'll Work On

• Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file.
• Investigates complaints/events in a timely manner. Maintains accurate entry of complaints in database. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes. Prepares customer letters with findings. Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants.
• Prepares technical reports of analysis/findings--Tracks returned products within the database, as appropriate; Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings; Interprets technical product specifications, Device History Records, or measurements obtained; and Utilizes safe bio-hazard and chemical handling practices at all times.
• Duties associated with either role: Is diligent of any unusual trends in product complaints; Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings); Archives complaint records or returned products & retrieves information on previous investigations; Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
• The Product Surveillance Analyst must be able to: Collaborate independently with other team members and departments needing product complaint information; Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management; Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance; and be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues).
• Train others in Product Surveillance product complaint handling. Provide support to Legal Dept on product complaints. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Pay and Shift [manufacturing only; if applicable]

The salary range for this position is $70,000-75,000 based on relevant education and experience.

Required Qualifications

• Associate's Degree plus relevant work experience

Preferred Qualifications

• B.S. in Healthcare / Sciences or similar engineering discipline.
• Minimum 2 years of related work experience with a good understanding of the specified functional area.
• Knowledge of global regulations for medical device reporting and medical terminology is a plus
• Strong written and oral communication skills are required. Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously. Good problem-solving and proficient computer skills are required.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally. Ability to maintain regular and predictable attendance.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The salary for this role is between:

N/A

JOB FAMILY:

Operations Quality

DIVISION:

NM Neuromodulation

LOCATION:

United States > Texas > Plano : 6600 Pinecrest

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 75 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf